New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especially in drug testing.
Key-highlights of the Amendment:
The amendment authorizes researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.
Modeling & Simulation (M&S) methodologies were employed to optimize formulation compositions, establish bioequivalence, predict plasma exposure, and create dissolution safe spaces for various pharmaceutical products. The studies involved in-silico trials, IVIVC modeling, and virtual bioequivalence assessments. These innovative approaches allowed the sponsors to reduce costs and timelines by minimizing the need for traditional clinical studies and demonstrating the bioequivalence of their products, ultimately leading to regulatory acceptance and greater flexibility in formulation development.
To learn how our in-silico experts at InSilicoMinds can revolutionize your pharmaceutical development process and help you achieve cost savings and regulatory success, talk to us today!
